Brown Adipose Tissue Clinical Trial
Official title:
The Role of Vitamin A in Brown Fat Activity and Energy Metabolism
NCT number | NCT02381483 |
Other study ID # | 1032/2013 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | April 15, 2018 |
Verified date | August 2018 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical
studies, however the role of retinoids in human brown fat physiology and energy metabolism
remains elusive. This study aims to identify a possible association between retinoid
metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using
FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic
profile of white and brown neck fat biopsies at room temperature and cold conditions in a
subset of the study participants. More detailed molecular studies (involving other potential
browning markers) will also be performed in adipocytes derived from human SVC.
The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects
will be repeatedly exposed to cold and circulating retinoid levels and other plasma
parameters will be measured at various time points.
Status | Completed |
Enrollment | 66 |
Est. completion date | April 15, 2018 |
Est. primary completion date | April 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Age 20 - 45 years. - Body mass index (BMI) 18.5 - 24.9 kg/m2 (lean) or 30.0 - 38.0 kg/m2 (obese) Exclusion Criteria: - Endocrine (except hyperlipidemia), cardiovascular (except hypertension), liver, kidney, inflammatory bowel, rheumatic, oncologic disease or any other chronic condition. - Medication for any of the above mentioned conditions. - Pregnancy - Metallic implants that are not MRI compatible |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between retinol/retinol-binding protein concentrations and cold-induced brown fat acitivity | A possible association between serum retinol and retinol-binding protein concentrations and cold-induced brown fat activity in lean and obese subjects, respectively, will be analyzed. | 6 years | |
Secondary | Analyses of potential BAT or browning markers in humans | 6 years | ||
Secondary | Association between BAT activity and energy expenditure | 6 years | ||
Secondary | Identification of new factors related to brown fat function | This is a very exploratory aim that involves a number of molecular tests. Therefore no single outcome measure can be defined here. Briefly, we will perform mRNA and miRNA analyses from BAT biopsies and plasma before and after cold exposure to identify new factors related to BAT function. Potential candidates will be tested in loss- or gain-of-function models in isolated human and/or murine adipocytes. In addition, the thermogenic effects of commercially available peptides, hormones, lipids, or steroid acids, will be tested in primary adipocytes. | 6 years |
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